Aripiprazole Augmentation of Antidepressants in PTSD - Full Text View

Purpose

The proposed investigation will determine the therapeutic potential of aripiprazole augmentation to a stable antidepressant regimen for reducing posttraumatic stress disorder (PTSD) symptoms, cognitive symptoms, psychotic symptoms, and depressive symptoms in veterans with PTSD.

Condition	Intervention	Phase
PTSD	Drug: Aripiprazole Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Aripiprazole Augmentation of Antidepressants in PTSD

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants

Drug Information available for: Aripiprazole

U.S. FDA Resources

Further study details as provided by Durham VA Medical Center:

Primary Outcome Measures:

Clinician Administered PTSD Scale (CAPS) [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
Mean change scores (Week 2 minus Week 6) in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).

A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
Brief Assessment of Cognition in Affective Disorders (BAC-A) [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 6 (Week 2 minus Week 6).
Positive and Negative Symptoms Scale (PANSS) [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.Mean change scores from Week 2 and Week 6 (Week 2 minus Week 6)

Secondary Outcome Measures:

Connor-Davidson Resilience Scale (CD-RISC) [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience. Change scores calculated at Week 2 and Week 6 (Week 2 minus Week 6).
Beck Depression Inventory, Second Edition (BDI-II) [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression. Scores range from 0 to 63 (higher scores suggest higher levels of depression). Change scores were calculated from Week 2 and Week 6 scores (Week 2 minus Week 6).

Enrollment:	14
Study Start Date:	March 2007
Estimated Study Completion Date:	August 2013
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Aripiprazole	Drug: Aripiprazole Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
Placebo Comparator: Placebo	Drug: Placebo Same as active drug.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Outpatient veterans with posttraumatic stress disorder (PTSD)
Receiving treatment with an antidepressant at a stable dose for 4 weeks
Male or female
Ages 18-65 years old

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489866

Locations

United States, North Carolina
Durham VAMC 508 Fulton Street
Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Durham VA Medical Center

Investigators

Principal Investigator:

Christine E Marx, MD, MA

Durham VAMC

More Information

No publications provided

Responsible Party:	Durham VA Medical Center
ClinicalTrials.gov Identifier:	NCT00489866 History of Changes
Other Study ID Numbers:	VA IRB#01163
Study First Received:	June 20, 2007
Results First Received:	September 16, 2011
Last Updated:	March 5, 2013
Health Authority:	United States: Institutional Review Board United States: Federal Government

Keywords provided by Durham VA Medical Center:

PTSD
Antidepressant
Aripiprazole
OEF
OIF

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Antidepressive Agents
Aripiprazole
Psychotropic Drugs

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013